# K111693: Philips Heartstart FR3 Automated External Defibrillator

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Oct 28, 2011 after 134 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K020715 (2002). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003565: Heartstream FR2 Aed, Model M3860A,M3861A, Agilent Technologies, Inc. (2000) Summary page 2.
- K003819: Heartstream Attenuated Defibrillation Pads, Model M3870A, Agilent Technologies, Inc. (2001) Summary page 2.
- K014157: HEARTSTREAMFR2 Aed with M3848A and M3849A, Models M3860A, M3861, M3840A, M3841A, Philips Medical Systems (2002) Summary page 2.
- K051632: Philips Heartstart FR2+ Automated External Defibrillator, Models M3860A, M3861A, M3840A, M3841A, Philips Medical Systems (2005) Summary page 2.
- K072812: Philips Heartstart Smartpads Iii, Philips Medical Systems (2008) Summary page 2.

## Cited in the summary but kept off the family tree
- K050040: MS-753 Mars Inflate-Read Blood Pressure Monitor, Mars Medical Products (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K130684: Philips Heartstart FR3 Automated External Defibrillator (2013), 0 descendants of its own
- K120350: Extended Life Battery (2012), 0 descendants of its own

## Recalls of this device
- Feb 6, 2014 · Class II · Z-1225-2014: Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed Circuit Board (PCB), which contains the circuitry that supplies energy to the device, could become separ

## Indications for use
The Models 861388 and 861389 are intended for use by trained responders to treat ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardias (VTs). The Models 861388 and 861389 are used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms: Unresponsiveness Absence of normal breathing If in doubt, apply the pads. The Models 861388 and 861389 are intended for adults and children over 55 pounds (25 kg) or 8 years old. The Models 861388 and 861389 are also intended for children under 55 pounds (25 kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child’s age or weight, do not delay treatment. Apply the pads as illustrated for a child and use the defibrillator. WARNING: Performance of the SMART CPR AUTO1 and AUTO2 settings for the CPR feature has not been established in patients under 55 Ibs (25 kg) or 8 years old. The Models 861388 and 861389 are intended for use by personnel who have been trained in its operation and qualified by training in basic life support (BLS), advanced life support (ALS) or other physician-authorized emergency medical response.

Source page: https://510kreport.com/device/K111693
Methodology: https://510kreport.com/methodology